Department of Health and Social Care

Update on the Independent Medicines and Medical Devices Safety Review

lord o'shaughnessy: My hon. Friend, the Parliamentary Under-Secretary of State for Health (Jackie Doyle-Price) has made the following statement:In February, the Government announced the establishment of the Independent Medicines and Medical Devices Safety Review. Baroness Cumberlege is in the process of conducting the review into what happened in each of the cases of Primodos, Sodium Valproate and Surgical Mesh, including whether the processes pursued to date have been sufficient and satisfactory, and to make recommendations on what should happen in future.Baroness Cumberlege has reported to the Department of Health and Social Care an early finding of her review relating to surgical mesh. Following a number of engagement meetings with patients she has concluded that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence (SUI).In letters to the Secretary of State, Parliamentary Under Secretary of State for Mental Health and Inequalities, Parliamentary Under Secretary of State for Health (Lords) and Chief Medical Officer, Baroness Cumberlege has set out a number of conditions that should be met ahead of the resumption of mesh procedures used to treat SUI:Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly;Surgeons report every procedure to a national database;A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;Reporting of complications via MHRA is linked to the register;Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh; andNICE guidelines on the use of mesh for SUI are published.Ministers in the Department of Health and Social Care have taken advice from the Chief Medical Officer and the senior clinicians in our health system on Baroness Cumberlege’s recommendation.Having reviewed Baroness Cumberlege’s recommendation and having considered the NHS’s progress in implementing the relevant NICE guidelines across the system, the Chief Medical Officer and senior clinicians have concluded that we should institute a pause in the use of vaginally inserted mesh to treat prolapse and the use of tape or slings to treat stress urinary incontinence. They have concluded that this should be done through implementation of a high vigilance programme of restricted practice. They have advised that this approach will allow the NHS to put in place a consistent, high-quality service that adequately meets the conditions set out by Baroness Cumberlege. Both the Chief Medical Officer and Baroness Cumberlege agree that we should not introduce a blanket ban of the relevant procedures, and that there will need to be some exceptions within the pause, within a high vigilance programme of restricted practice. The Department has accepted Baroness Cumberlege’s recommendation, and the advice from the Chief Medical Officer and senior clinicians.NHS England is now working with other agencies in the system to implement the pause quickly and safely. A clinical advisory group is being established to ensure that appropriate measures are put in place to give effect to the high vigilance programme. NHSE will be writing to providers imminently.NHS England and NHS Improvement will ensure that provider medical directors and nurse directors are equipped with timely advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.The Department will work with Baroness Cumberlege and senior clinicians in the NHS to act with pace on this decision. The Department is very grateful to Baroness Cumberlege and her review team for listening to the voice of patients and for intervening on their behalf; and to the Chief Medical Officer and senior clinicians for their further advice and commitment to putting in place safe and effective changes for patients.


This statement has also been made in the House of Commons: 
HCWS841

Department for Environment, Food and Rural Affairs

post June Environment Council

lord gardiner of kimble: My Hon Friend the Parliamentary Under Secretary of State for the Environment (Dr Thérèse Coffey MP) has today made the following statement.My Noble Friend the Parliamentary Under Secretary of State for Rural Affairs and Biosecurity (Lord Gardiner of Kimble), attended EU Environment Council on 25 June in Luxembourg.I wish to update the House on the matters discussed.Directive on Drinking Water (recast) – Policy debateThe Council held a policy debate on the Drinking Water Directive (8924/18), focusing on materials in contact with water (Article 10) and access to water (Article 13). Most Member States, including the UK, did not agree with the Commission’s proposed approach to Article 10 – citing the need for EU level harmonised hygiene requirements and for the inclusion of all products from source to tap as a way to protect public health. Several Member States and the Commission, drew attention to the technical non-paper from the “4MS initiative” (France, UK, Germany, the Netherlands) as a basis for ongoing work.On Article 13, several member states including the UK, supported the principle of access to water, but raised issues of subsidiarity. Most Member States called for greater flexibility, with some member states remarking that the Directive was not the right place to address this issue. Additionally, the UK drew attention to the importance of adhering to World Health Organisation guidance to underpin the proposal.CO2 cars and vans regulation – policy debateThe Council held a policy debate on CO2 emissions from cars and vans (9728/18), with the Presidency seeking views on the level of ambition and incentives for low and zero emission vehicles.Council was divided into four camps; some member states pushed for over 40% reductions in fleet emissions; others, including the UK did not go as far as this group, but pressed for more ambition than the Commission proposal of a 30% reduction. Another group of member states supported the Commission proposal, whilst others thought that even this was too ambitious, and called for technological neutrality to help incentivise low and zero emission vehicles.Council Conclusions on the EU Action Plan for the Circular EconomyThe Council adopted Conclusions on the Circular Economy Action Plan (10221/18). Member states including the UK noted the importance of addressing single use plastics, with Lord Gardiner highlighting activities across the UK in this area.AOB itemsThe following items were also discussed under Any Other Business.1. Current legislative proposalsThe Commission introduced four new legislative proposals: LIFE programme (9651/18); water reuse (9498/18); single use plastics (9465/18); and environmental reporting (9617/18). The Commission pushed for speedy consideration of the single use plastics and environmental reporting proposals in particular. Several Member States welcomed the proposals, with particular focus on the plastics proposal.2. EU Pollinators initiative The Commission introduced the EU Pollinators initiative (9744/18). This received support from several member states including the UK.  3. Management of chemicals and waste post 2020 Council noted the Swedish paper on establishing a high ambition alliance on the management of chemicals and waste (10104/18). This gathered support from a number of member states.   4. Convention on Biological Diversity France introduced their paper on COP15 of the Convention on Biological Diversity, urging Member States to increase efforts to meet the targets on limiting biodiversity loss. This was welcomed by the UK among others.  5. Commission reports on recent international meetingsThe Council noted the information provided by the Commission, Poland and Germany on several international meetings including EU for Talanoa, Ministerial on Climate Action (MoCA), and the Ninth Petersberg Climate Dialogue. A small number of Member States intervened to support EU climate leadership and ambition. The Commission welcomed their support, and noted that with the recently agreed Renewable Energy and Energy Efficiency targets, the EU would de facto be in a position to reduce its emissions by 45% by 2030 compared to 1990 levels.6. CO2 from heavy duty vehicles The Commission presented their proposal for CO2 emission standards for Heavy-Duty Vehicles (8922/18), and called for agreement on the file before the end of the European Parliamentary term.7. Paris Agreement as an essential clause in EU agreementsFrance presented a proposal in relation to the Paris Agreement and EU cooperation and political dialogue agreements, or in the absence of these, trade agreements. There was some discussion between Member States and the Commission, and it was noted that further careful consideration of the proposal would be needed.